The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 4
- 主要终点
- 24-hour Systolic Ambulatory Blood Pressure (mmHg)
研究概览
简要总结
This is a 5-year randomized controlled trial in two large healthcare systems (Madison and Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact on blood pressure among 310 geographically and racially/ethnically diverse young adults.
详细描述
Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and hypertension control (secondary) after 6 and 12 months, compared to usual clinical care.
Aim 2. To evaluate the effect of MyHEART on hypertension self-management behavior (behavioral outcomes) at 6 and 12 months, compared to usual clinical care.
Aim 3. To examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and capable of giving written informed consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Males and females ages 18-39 years old at the start of the study (inclusive)
- •A minimum of two hypertension ICD-10 coded visits with a provider (physician [MD, DO], physician assistant, nurse practitioner) on different dates in the last 24 months, with at least one code in the past 18 months
- •Medically homed at an IRB approved healthcare system
排除标准
- •History of medically determined Congestive Heart Failure
- •Unable to provide informed consent (i.e., activated healthcare power of attorney)
- •Unable or unwilling to travel to local clinic for research visits
- •Currently residing in a skilled nursing facility
- •Diagnosed with sickle cell anemia or cystic fibrosis
- •Diagnosed with stroke, myocardial infarction, and/or coronary artery revascularization in the past 2 years
- •Syncope while exercising or doing strenuous activity within past 12 months
- •Currently prescribed warfarin, novel oral anticoagulant, or insulin
- •Planned organ transplant or prior transplant in the past 5 years
- •Chemotherapy or radiation therapy within 6 the past months
- •Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment
- •Current participation or planning to participate in another clinical trial in the next 12 months
- •Pregnant or planning to become pregnant in the next 12 months
- •Planning to leave the geographic area in the next 6 months
- •Health condition that will limit both increasing physical activity and changing diet
- •Illegal drug use (other than marijuana) in the past 30 days
- •Unable to read or communicate in English
- •Currently on dialysis or seeing a Nephrologist
- •Unaware or denies history of high blood pressure or hypertension
- •Between-arm blood pressure difference >20 mmHg
- •White Coat Hypertension (24-hour ambulatory monitoring)
- •Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site investigators
- •Prisoners
结局指标
主要结局
24-hour Systolic Ambulatory Blood Pressure (mmHg)
时间窗: baseline, 6 month, and 12 month follow-up
24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
Clinic Diastolic Blood Pressure (mmHg)
时间窗: baseline, 6 month, and 12 month follow-up
Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months.
24-hour Diastolic Ambulatory Blood Pressure (mmHg)
时间窗: baseline, 6 month, and 12 month follow-up
24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
Clinic Systolic Blood Pressure (mmHg)
时间窗: baseline, 6 month, and 12 month follow-up
Systolic Blood Pressure measured at baseline, 6 months, and 12 months.
次要结局
- Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment(baseline, 6 month, and 12 month follow-up)
- Home Blood Pressure Monitoring Frequency(baseline, 6 month, and 12 month follow-up)
- Perceived Competence as Assessed by the Perceived Competence Scale for Diet(baseline, 6 month, and 12 month follow-up)
- Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet(baseline, 6 month, and 12 month follow-up)
- Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment(baseline, 6 month, and 12 month follow-up)
- Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet(baseline, 6 month, and 12 month follow-up)
- Number of Participants That Achieve Hypertension Control at 6 Months(up to 6 months)
- Standing Weight (kg)(baseline, 6 month, and 12 month follow-up)
- Perceived Competence as Assessed by the Perceived Competence Scale for Exercise(baseline, 6 month, and 12 month follow-up)
- Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment(baseline, 6 month, and 12 month follow-up)
- Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment(baseline, 6 month, and 12 month follow-up)
- Physical Activity as Assessed by the Godin Physical Activity Questionnaire(baseline, 6 month, and 12 month follow-up)
- Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise(baseline, 6 month, and 12 month follow-up)
- Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise(baseline, 6 month, and 12 month follow-up)
- Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise(baseline, 6 month, and 12 month follow-up)
- Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet(baseline, 6 month, and 12 month follow-up)
- Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise(baseline, 6 month, and 12 month follow-up)
- Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet(baseline, 6 month, and 12 month follow-up)